BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 20065496 · Received August 26, 2024

    Report

    Report Number
    3014732157-2024-00598
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 7, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FRN
    UDI-DI
    00811505030320
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: REPORTED/INCIDENT DATE: 08/07/2024 OFFICE LOCATION: (B)(6) PUMP SERIAL NUMBER: (B)(6) TYPE OF ALARM: NO ON-SCREEN ALERT PUMP INFUSING? NO PATIENT HARM? NO HARD POWER RESET? YES RESULT OF POWER RESET? ALARM RESOLVED REPORTED BY: HHO NURSES -"THE NURSES HAVE A CHEMO PUMP THAT IS ALARMING. THE SCREEN IS LOCKED AND NOT RESPONDING TO TOUCH. UNABLE TO POWER DOWN." -NO ALERT ON SCREEN; SCREEN DISPLAYED LOG IN KEYPAD. -CHANNEL LIGHTS WERE RED ON BOTH CHANNELS. INSTRUCTED TO HAVE NURSES HOLD DOWN POWER BUTTON FOR A FULL 30 SECONDS. PUMP POWERED DOWN. UPON RESTART, NO ALARM. LOGS PULLED. NURSES INSTRUCTED TO PERFORM A TEST INFUSION OF 30 ML OVER 15 MINUTES (RESULT PENDING). A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: PROCESSOR HARDWARE FAILURE (LINUX CORE) AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    THE PUMP WAS RETURNED DUE TO THE PUMP ALARMING AND THE TOUCHSCREEN NOT RESPONDING TO TOUCH. DURING INVESTIGATION, UNABLE TO SET PUMP ON STANDBY MODE, IT CAN ONLY BE STOPPED BY A HARD SHUT DOWN. LOGS FROM CUSTOMER WERE REVIEWED AND CALL OUT A SOM FAILURE. THE PUMP WAS ABLE TO PASS INFUSION TEST AT THE CUSTOMER LOCATION. THE SOM WILL NEED REPLACED TO ALLOW DEVICE TO FULLY REVERT BEFORE TESTING CAN BE CONDUCTED. NO OTHER DAMAGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276492 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown